Here is the introduction to a very long and technical Amgen press release as featured Sunday on PRNewswire.com:
THOUSAND OAKS, Calif., Oct. 10 /PRNewswire-FirstCall/ — Amgen (Nasdaq: AMGN) today announced results from two integrated analyses of head-to-head pivotal Phase 3 trials comparing denosumab to Zometa® (zoledronic acid), the current standard of care in the prevention of skeletal related events (SREs) in patients with advanced malignancies involving bone. In these separate analyses, denosumab demonstrated a clinically meaningful, consistent and robust treatment effect across tumor types in the reduction of SREs, and also prevented clinically relevant increases in pain, compared with Zometa. A separate presentation highlighted the meaningful burden that SREs pose to the healthcare system. These analyses were presented at the 35th European Society for Medical Oncology (ESMO) Congress being held in Milan, Italy.
“Bone metastases and their subsequent complications, such as a fracture, are devastating events for advanced cancer patients and costly to the healthcare system,” said Allan Lipton, M.D., professor of Medicine & Oncology, M.S. Hershey Medical Center of the Pennsylvania State University. “This analysis of the largest registration program ever undertaken in bone metastases demonstrates that denosumab can offer a clinical advance over Zometa in delaying or preventing these bony complications, as well as the pain that frequently results from them. These efficacy gains coupled with the convenience of a subcutaneous injection and no need for renal monitoring make denosumab an attractive option for these patients.”
Since most multiple myeloma patients receive regular IV infusions of either Aredia or Zometa, this report is certainly relevant. Myeloma docs have been excited about denosumab for years. The hope is denosumab will have fewer side-effects than Zometa. The studies sited in this release seem to confirm some of that.
Is denosumab more effective than Zometa? According to Amgen: The analysis showed that denosumab was superior to Zometa in delaying time to first on-study SRE by 17 percent (median time to first skeletal related event of 27.7 months for denosumab and 19.5 months for Zometa, p <0.0001). Denosumab was also superior to Zometa in delaying time to first-and-subsequent on-study SRE by 18 percent (p<0.0001). Overall disease progression and survival were similar for both groups.
I couldn’t find any claims or mention of anti-myeloma activity in the release. This is Novartis’ (the maker of Zometa) counter to the future market release of denosumab.
I should pause here and disclose that I will be doing some paid, freelance work for Novartis next week.
There have been some delays in getting denosumab approved by the FDA. In many ways, the development of denosumab mirrors those of carfilzomib. Both are highly anticipated. Both have been promoted aggressively by their respective manufacturers, Amgen and Onyx. And both drugs may have trouble living up to the “hype” surrounding their development. Are expectations unrealistic for these two new “wonder” drugs? We should know more following the ASH meetings this December. It will be interesting watching the drama play-out in 2011. Hopefully multiple myeloma patients won’t get lost in all of the promotion, posturing and politics.
Feel good and keep smiling! Pat